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New bladder cancer drug shows promise in early trial

NCT ID NCT07222488

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study tests a new drug called MK-3120 for high-risk non-muscle invasive bladder cancer. After standard tumor removal, 45 participants will receive the drug directly into the bladder. The main goals are to check safety and how well people tolerate it, while also looking at tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-3120 (SKB410), a biologic given directly into the bladder
What this could lead to
If it works, this could offer a new treatment option for people with high-risk bladder cancer that hasn't spread to the muscle.
What could go wrong
This is an early-phase trial with only 45 participants, so results may not apply broadly. Side effects like bleeding or severe lab abnormalities are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has histologically confirmed carcinoma in situ (CIS) +/- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally. * Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by attainment of a visually complete resection of all papillary tumors (Ta and T1). * Is either: a) Bacillus Calmette-Guérin (BCG)-naïve, defined as either having never received BCG or having received BCG more than 2 years before CIS +/- papillary high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post-BCG OR; b) BCG-exposed and received adequate BCG therapy and had recurrence of CIS +/- papillary high-risk NMIBC \>12 months but ≤24 months after the last BCG dose. * Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy. * Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Exclusion Criteria: * Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC). * Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years. * Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture. * Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours). * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known active central nervous system metastases and/or carcinomatous meningitis. * Has active infection requiring systemic therapy. * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, or has current pneumonitis/ILD. * Has not adequately recovered from major surgery or has ongoing surgical complications.

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ superficial urinary bladder carcinoma urinary bladder carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer Urinary bladder neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Akershus Universitetssykehus ( Site 0091)

    RECRUITING

    Lorenskog, Akershus, 1478, Norway

  • Ankara University Health Practice and Research Hospitals ( Site 0132)

    RECRUITING

    Ankara, 06620, Turkey (Türkiye)

  • CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011)

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Carolina Urologic Research Center ( Site 0006)

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Centro Ricerche Cliniche di Verona ( Site 0072)

    RECRUITING

    Verona, Veneto, 37134, Italy

  • European Interbalkan Medical Center ( Site 0051)

    RECRUITING

    Thessaloniki, 570 01, Greece

  • Gustave Roussy ( Site 0041)

    RECRUITING

    Villejuif, Val-de-Marne, 94805, France

  • Hospital Universitario 12 de Octubre ( Site 0112)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Virgen de la Victoria ( Site 0111)

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Koc Universitesi Hastanesi ( Site 0133)

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Medizinische Universität Wien ( Site 0021)

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

  • Michael G Oefelein Clinical Trials ( Site 0005)

    RECRUITING

    Bakersfield, California, 93301, United States

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081)

    RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Rabin Medical Center ( Site 0062)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rutgers Cancer Institute of New Jersey ( Site 0007)

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • UZ Gent ( Site 0031)

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Urology Austin, PLLC ( Site 0008)

    RECRUITING

    Austin, Texas, 78759, United States

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